MAUDE Adverse Event Report: NOBEL BIOCARE USA INC REPLACE SELECT TAPERED TIU 6.0 6.0X8MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	36110
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed because primary stability could not be achieved.

• Brand Name: REPLACE SELECT TAPERED TIU 6.0 6.0X8MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer (Section G): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 17201980
• Report Number: 2027971-2023-092533
• Device Sequence Number: 6741982
• Product Code: DZE
• UDI-Device Identifier: 07332747160352
• UDI-Public: (01)07332747160352(10)13130208(17)270305
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 36110
• Device Catalogue Number: 36110
• Device Lot Number: 13130208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female